Sr. Manager, R&D Quality

Scorpion Therapeutics; Waltham (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Scorpion Therapeutics, a biopharma focused on autoimmune and rare diseases, seeks a Senior Manager, R&D Quality in Waltham, MA. You will oversee the QA systems across clinical development, lead audits, and ensure data integrity and TMF compliance. This role requires 8+ years in biotech QA, deep FDA/ICH/EMEA knowledge, and strong leadership.

Office-based with a 3-day in-office requirement per week, you will drive continuous improvement and a quality culture through training and SOP authoring.

Qualifications

• Bachelor's in Life Sciences or related field.
• 8+ years of biotech/pharmaceutical R&D QA experience.
• Deep knowledge of FDA, ICH, and EMEA regulations.
• Strong leadership, communication, and project management skills.

Responsibilities

• Manage the Quality Management System.
• Conduct audits (investigator, vendor, systemic).
• Support inspection readiness.
• Oversee vendor qualification and oversight.
• Ensure data integrity and TMF compliance.
• Author SOPs.
• Lead process improvements.
• Promote a quality culture through training.

Skills

Leadership

Communication

Project management

Data integrity

Education

Bachelor's degree in Life Sciences or related field

Tools

GxP standards

Microsoft Office

Job description

Senior Manager, R&D Quality at a biopharma focused on autoimmune and rare diseases, overseeing quality assurance activities across clinical development.

Responsibilities

• manage the Quality Management System
• conduct audits (investigator, vendor, systemic)
• support inspection readiness
• oversee vendor qualification and oversight
• ensure data integrity and TMF compliance
• author SOPs
• lead process improvements
• promote a quality culture through training

Requirements

• Bachelor's in Life Sciences or related field
• 8+ years of biotech/pharmaceutical R&D QA experience
• deep knowledge of FDA, ICH, and EMEA regulations
• strong leadership, communication, and project management skills
• proficiency in GxP standards and Microsoft Office

High Value

• experience in clinical QA within biotech/pharma
• familiarity with GLP, GCP, GVP, and risk-based quality management
• hands‑on with audits, vendor oversight, inspection support, and data integrity in clinical systems
• focused on cGMP compliance and continuous improvement

Work Setup

office-based in Waltham, MA, with a 3-day in-office requirement per week.